System for medical protocol management

ABSTRACT

A system for treating orthopedic injuries by presenting a set of treatment protocols; approving a treatment protocol from among the presented set of treatment protocols; capturing information identifying the approved treatment protocol from among the set of presented protocols; and generating information from the captured information into a form compatible with a handheld computer adapted for connection to an orthopedic sensor system. The generated information includes parameters of the identified approved treatment protocol. The process may also include the steps of basing the presented set of treatment protocols upon a database of historic patients, orthopedic injuries, treatment protocols and outcomes, and retaining information about the current patient, the patient&#39;s injury, treatment protocol and outcome.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The current application is a continuation of U.S. patentapplication Ser. No. 09/416,192, filed on Oct. 11, 1999, entitled“SYSTEM FOR ORTHOPEDIC TREATMENT,” as renamed “SYSTEM FOR MEDICALPROTOCOL MANAGEMENT,” which is hereby incorporated by reference herein.

[0002] The present invention relates to orthopedic treatment and, inparticular, the present invention relates to systems for orthopedictreatment in which patient treatment protocols are reduced todigitalized representations for use in conjunction with portablecomputerized or digitalized orthopedic treatment devices. The presentinvention also relates to selection or creation of an appropriatepatient treatment protocol, as well as intervention and control tomodify the patient treatment protocol. In particular, this aspect of thepresent invention also relates to modification of a patient treatmentprotocol when the modification is contingent upon certain events relatedto feed-back data recorded by a computerized orthopedic treatmentdevice.

[0003] Orthopedic treatment historically involved a treatmentprofessional, normally a physician, examining and diagnosing anorthopedic injury in a patient, prescribing a treatment protocol ofactivities or exercises for the patient to follow in order to facilitatehealing, and subsequent re-examination to assess patient progress.Additionally, the patient was traditionally guided and assisted infollowing the prescribed treatment protocol by other treatmentprofessionals, such as physical therapists, who could inform and advisethe attending physician concerning patient compliance with the protocoland communicate and assist with the patient to provide desired activitydetails and elicit patient response. The traditional treatment pathoften included either hospitalization or patient visits at a physicaltherapy facility.

[0004] In modern times, financial pressure upon the medical arts and thesurrounding medical industry has increased the number of patients eachphysician must treat and reduced the rate of hospitalization. There is atendency to employ physical therapy facilities, as well as reduce thedirect supervision of the patient activities by the physical therapist.Computerized devices have been developed that at least augment thephysical therapist contact, and monitor patient activities under atreatment protocol. One particularly innovative device system, the IZEXsensor-instrumented orthosis and associated hand-held Smart IDEA™computer/communicator, not only replaces some of the physicaltherapist's function of (1) advising and instructing the patient and (2)advising the attending physician of patient outcome and compliance, butalso allow an improved (quantitative) measuring and monitoring ofpatient rehabilitation activities and exercise parameters, such aseffort exerted in rehabilitation exercises or stress applied to theorthopedic injury. This improved monitoring enables exploitation of along observed and literature-documented phenomenon of improved recoveryin response to appropriately applied exercises to orthopedic injuries.The topic of accelerated and improved recovery through the use ofcontrolled bio-feedback based rehabilitation has been reviewedextensively by one of the present inventors in patents U.S. Pat. No.5,052,375; U.S. Pat. No. 5,368,546; U.S. Pat. No. 5,484,389; U.S. Pat.No. 5,823,975; and U.S. Pat. No. 5,929,782 and the entire disclosures ofthese patents are incorporated herein by reference.

[0005] In spite of advances such as the IZEX SmartIDEA™, the ultimategoal of efficiently achieving an optimal yet accelerated recoveryoutcome has remained elusive. This is, at least in part, because theutilization of the IZEX™ orthosis brace system and SmartIDEA™computer/communicator previously have continued to rely upon a treatmentprofessional performing an examination, generating a diagnosis andsubsequently providing a treatment protocol for the injured patient. TheSmartIDEA™ hand-held computer was then programmed based upon theprotocol. The treatment professional may not readily know nor haveavailable information concerning the optimal treatment protocol for anaccurately diagnosed injury. It would be a significant advance inorthopedic treatment if a physician or other treatment professionalcould be rapidly advised concerning optimal treatment information basedupon up-to-date experiential outcomes of similar treated injuries. Itwould also be a significant advance if the physician or treatmentprofessional could leverage their own expertise and their colleagues'most recent knowledge to appropriately modify and adapt previouslysuccessful protocols for a new patient. It would also be a significantadvance if the protocol could be installed in a handheld computer(monitoring device/computer/communicator) device with ease andefficiency. Additionally, it would be a significant advance to allowappropriate progress-based and time-based modification of the patient'sprotocol. Modification may be best thought of as intervention.Intervention, most particularly real-time modification, intorehabilitation exercise protocols by a patient or in response to apatient request or by a treatment professional or by an automatedcomputer algorithm, where such modification is limited by reasonableconstraints, would also offer further progress toward the goal ofefficiently achieving an optimal, yet accelerated, orthopedic recoveryoutcome. A system which provides real-time intervention can also allowdelayed intervention. Intervention can be initiated by the patient, bythe treatment professional, or by the automated computer system. Thefollowing system provides such advances to the orthopedic arts.

BRIEF DESCRIPTION OF THE FIGURES

[0006]FIG. 1 is a schematic diagram of the relationship between patientand treating professional, as process participants, and schematicallyindicating equipment of a prior art treatment process;

[0007]FIG. 2 is a schematic diagram of the relationship between patientand treating professional, as process participants, and schematicallyindicating equipment used in another prior art treatment process;

[0008]FIG. 3 is a schematic diagram of the relationship between patientand treating professional, as process participants, and schematicallyindicating equipment used in still another prior art treatment process;

[0009]FIG. 4 is a schematic diagram of the relationship between multiplepatients and a treating professional, as process participants, andschematically indicating equipment and relationships in a treatmentsystem according to the present invention;

[0010]FIG. 5 is a schematic diagram of the relationship between multiplepatients and multiple treating professionals, as process participants,and schematically indicating equipment and relationships in a treatmentsystem according to another embodiment of the present invention;

[0011]FIG. 6 is a schematic diagram of the relationship between patientand treating professional, as process participants, and schematicallyindicating equipment and participants as used in a treatment systemaccording to yet another embodiment of the present invention;

[0012]FIG. 7 is a schematic diagram of the relationship between multiplepatients and multiple treating professionals, as process participants,and schematically indicating equipment and participants in a treatmentsystem according to still another embodiment of the present invention;

[0013]FIG. 8 is a schematic diagram of another embodiment of the presentinvention involving data storage and use of data from an historicdatabase in an embodiment of the present invention;

[0014]FIG. 9 is a schematic of information processing systems within thepresent invention in order to effect treatment of an orthopedic injury,through operations such as data generation, collection, signaling,analysis, modification, review and reporting;

[0015]FIG. 10 is a more detailed view of portions of FIG. 9 concerningcreating an exercise protocol;

[0016]FIG. 11 is a representative compliance report for a hypotheticalpatient;

[0017]FIG. 12 is a set of representative patient recovery reports for ahypothetical patient, with FIG. 12A presenting range of motion plottedagainst exercise session number, FIG. 12B presenting strength plottedagainst exercise session number, FIG. 12C presenting fine motor recoveryplotted against exercise session number, and FIG. 12D presentingneuromotor and muscular hits plotted against exercise session number;

[0018]FIG. 13 is a representive recovery goal analysis for ahypothetical patient;

[0019]FIG. 14 is a representative graphical presentation report for ahypothetical patient being treated with a protocol modified three timesto be more difficult and showing patient progress after eachmodification or intervention; and

[0020]FIG. 15 is a representive set of multiple challenge levels A, B,and C for protocol modification.

SUMMARY OF THE INVENTION

[0021] The present invention is a system for treating an orthopedicinjury. In a first embodiment, the system includes a definition of aprotocol for biological manipulation to be performed upon a patient withan orthopedic injury to be treated according to a coordinated, monitoredrecovery scheme; a monitoring device, which might be a personalorthopedic restraining device appropriately equipped with a transducer,portable and attachable to a patient with an orthopedic injury to betreated, for monitoring patient activity relative to the protocol oralternatively, a non-restraining monitoring device such as a Therabelt;a portable or more preferably a handheld computer or a palmtop computer;a central processor or computer, segregated from the portable computer,the central computer including a file server, a database, memory,processing, display and communications and including means to generatethe protocol; a communication system allowing communication between apair of distinct computers, most particularly the portable and thecentral computer; and an analysis interaction algorithm, preferablyavailable to or at the central computer.

[0022] The system of the invention may also be understood, in oneembodiment, in terms of a process or in another embodiment, in terms ofan apparatus. Considered as a process, the invention includes the stepsof a.) biologically manipulating a patient for coordinated monitoredrecovery (such monitoring may be either biophysically or computermonitored); b.) providing a monitoring means, such as a transducerequipped personal orthopedic restraining device (PORD), oralternatively, a transduce equipped belts, such as a Theraband typedevice to monitor patient performance of protocol exercises; c.)providing a portable computer, preferably a handheld computer, where thehandheld computer includes capabilities for memory, processing, display,recording monitored information from the monitoring means (such as aPORD), and data transmission and reception; d.) providing a centralprocessor (segregated from the portable computer), the central computerincluding a file server, a database, memory, processing, display andcommunications; e.) communicating between the provided pair of distinctcomputers; and f.) analyzing monitored data by an analysis interactionalgorithm (preferably by the central computer).

[0023] Considered as a device, the invention includes a.) means forbiologically manipulating a patient for coordinated monitored recovery(such monitoring may be either biophysically or computer monitored); b.)a monitoring means, such as a transducer equipped personal orthopedicrestraining device (PORD), or alternatively, a transducer equipped belt,such as a Theraband type device to monitor patient performance ofprotocol exercises; c.) a portable computer, preferably a handheldcomputer, where the handheld includes capabilities for memory,processing, display, recording monitored information from the monitoringmeans (such as a PORD), and data transmission and reception. Theportable or handheld computer is, at least at some time, incommunication with the monitoring means and preferably includessufficient information concerning the patient's biological manipulationprotocol to compare monitored information with the goal protocolinformation; d.) a central processor or computer (segregated from theportable computer), the central computer including a file server, adatabase, memory, patient data outcome and compliance processing,display and communications; e.) communication means between the providedpair of distinct computers; and f.) analysis of monitored data by ananalysis interaction algorithm (preferably by the central computer oralternatively another computer, distinct from the handheld computer, andmost preferably which is in communication with the central computer).

[0024] In a preferred embodiment, the earlier mentioned processembodiment further includes steps to generate information about aprescribed protocol for treating the orthopedic injury of a patient.Such generated information may be in the form of a script, which willthen be used in a handheld computer and orthosis device combination totreat an orthopedic injury. The additional process steps include: g.)presentation of a set of treatment protocols. The set of protocols to bepresented includes at least one treatment protocol. The presentationmight be on a display screen or a paper printout or similar hardcopy orboth. h.) approval of a treatment protocol from among the presented setof treatment protocols. This step is preferably undertaken by atreatment professional employing professional judgement and, generally,the approval is made in light of further information about the treatmentprotocol which is being approved. i.) capturing information identifyingthe approved treatment protocol from the set of presented protocols; andj.) generating information from the captured information into a formcompatible with a handheld computer adapted for connection to anorthopedic sensor system, wherein the generated information includesparameters of the identified approved treatment protocol. Additionallythe method may include e.) communication from the portable monitoringand communication device of information concerning interactions,communication exchange and/or patient exercise; and f.) modification ofthe treatment protocol; and g.) monitoring the new protocol.

[0025] The present invention includes a number of further embodiments.One particularly notable embodiment involves a database of historicinformation of earlier patients, their injuries, their actual treatmentsprotocols as performed, and resulting outcomes and a communications anddata method to connect the two optimizing functions together. Newinformation can be accumulated in such a database while performing theprocess of certain embodiments of the present invention and informationfrom the database is made available and utilized in other embodiments ofthe present invention.

[0026] The present invention in another embodiment is a system fortreating an orthopedic injury. The system includes a handheld computeradapted for connection to an orthopedic sensor system, a centralcomputer including a historic database of orthopedic injuries, patientcharacteristics, treatment protocols and outcomes. The system allows aninquiry of the database, i.e. the central computer is queried to causepresentation of a set of treatment protocols to a treatmentprofessional. The treatment professional approves a treatment protocolfrom the set and the system generates formatted parameters correspondingto the approved treatment protocol for installation in the handheldcomputer. Once installed with such parameters, the handheld computer canmediate the approved treatment protocol when it is connected to theorthopedic sensor system. The system further includes monitoringperformance of the patient in response to the treatment protocol andupdating the historic database with the monitored performanceparameters. The system further includes the possibility for treatmentintervention in the form of modification of the formatted treatmentprotocol parameters in real-time in response to updates to the historicdatabase or in response to patient data recently sent to the computer.Data which is transmitted to the central computer can be analyzed orcompared against other databases and sent on for other analysis. Whenthe data is communicated, secure communication schemes may be optionallyemployed.

DETAILED DISCLOSURE OF PREFERRED EMBODIMENTS

[0027] A background for better understanding of the present inventionmay be gained by initially considering some earlier innovationsdeveloped by one of the inventors. As shown in FIG. 1, treatment of apatient 12 with an orthopedic injury, such as by way of example, aninjury at or adjacent the patient's knee, is accomplished by fitting thepatient with an orthosis, preferably, a personal orthopedic restrainingdevice (PORD) 14. The PORD 14 serves two important functions. First, itrestrains or restricts motion of the patient's leg at the knee tomotions consistent with a treatment protocol, and second, it measures aphysical parameter of the patient's exercise, such as stress whenexercising and knee angle when flexing or extending. The PORD 14includes a transducer to accomplish such measurement. The transducer ofthe PORD 14 is connected to a handheld computer 16 which recordstransducer output signals. The handheld computer 16 is adapted forconnection to an orthopedic sensor system. The handheld computer 16 alsoprocesses the transducer signals and provides the processed informationboth directly to an attending treatment professional 18 and to thehandheld computer memory for later retrieval. For example, the processedinformation may be provided as a display on the handheld computer 16.The treatment professional 18 may also install sufficient information inthe handheld computer 16 by way of a desktop PC 18 a to compare thepatient's level of compliance with the exercise treatment protocol. Anexemplary handheld device such as a SmartIDEA (tm) device is availablefrom IZEX Technologies, Inc., Golden Valley, Minn.

[0028] As shown in FIG. 2, the handheld computer 16 can also communicatewith another computer 20. This second computer 20 may be a centralcomputer 20 segregated from the handheld computer 16, PORD 14 andpatient 12 and can process the recorded, preferably preprocessed,information. The communication may be via modem over telephone lines orvia cellular radio-telephone transmission. The treatment professional 18can review the processed results at the central computer 20 location,for example, as a screen display or a hardcopy printout.

[0029] As shown in FIG. 3, the treatment professional 18 may use apersonal computer (PC) 22 to communicate with the central computer 20 ordirectly to the handheld computer 16. The PC 22 may be adjacent thecentral computer 20 and the communication take place over a serialcable, or it may be remote and use modems over telephone lines. In thissystem, the treatment professional 18 might send a signal to thehandheld computer 16 to tell patient 12 to exercise.

[0030] In the present invention, as shown in FIG. 4, the same treatmentprofessional 18, using PC 22, may treat another patient 24 with anotherPORD 26 communicating with another handheld computer 28 which in turncommunicates with the central computer 20. The number of patients 12 and24 being treated may be expanded and is not limited to only twopatients. The handheld computers 16 and 28 may, most preferably, includeadditional output capabilities selected from the group consisting ofRS-232 output, USB output, parallel port output, light output, textual,graphical, audible output, Ethernet input, RF communications output, IRcommunications output and tactile output.

[0031] In another embodiment, as shown in FIG. 5, another treatmentprofessional 30, using PC 32, may treat the other patient 24 while theoriginal treatment professional 18 treats the original patient 12.Treatment of the patients 12 and 24 can also be shifted betweentreatment professionals 18 and 30 as schedules and responsibilitiesdictate. Alternatively, review, consultation, and related communicationbetween treatment professionals 18 and 30 is possible, and may takeplace through central computer 20 or by telephone or in face-to-facediscussions. The number of patients being treated and/or the number oftreatment professionals may be expanded and is not limited to only two.

[0032] In another embodiment, shown in FIG. 6, another central computer34 communicates with the original central computer 20 and the treatmentprofessional 18 uses original PC 22 to communicate with the anothercentral computer 34 rather than directly with the original centralcomputer 20. Communication between the central computers 20 and 34 maybe via modem connections over telephone lines or more preferably over anInternet or intranet network. It should be recognized that the centralcomputer 34 can be one of many central computers on a network, that thenetwork is not limited to only two central computers and that thecommunications between the two central computers 20 and 34 may be passedthrough other computers or devices rather than directly between the twocomputers 20 and 34.

[0033] In another embodiment, shown in FIG. 7, the central computer 34communicates with the original central computer 20 and the treatmentprofessionals 18 and 30 uses original PC 22 and additional PC 32respectively to communicate with the additional central computer 34rather than directly with central computer 20. Communication between thecentral computers 20 and 34 may be via modem connections over telephonelines or more preferably over an Internet, either public or private, orintranet network. Patients 12 and 24 with another PORD 26 communicatingwith another handheld computer 28 which in turn communicates with thecentral computer 20. The number of patients being treated may beexpanded as may the number of treatment professionals directingtreatment. Additionally, attending responsibility for patients may berotated amongst the treatment professionals. In a variation of thissystem, any or all of handheld computers 16 and 28 and PCs 22 and 32 maycommunicate with either central computer 20 or 34 or other likecomputers on an intranet network or over the Internet. Similarly, thePCs 22 and 32 may connect to other central computers participating inand communicating with the central network. It should also be recognizedthat either or both of the treating professionals 18 and 30 might beusing a networked PC or a workstation of a network.

[0034] In a further embodiment of the system of the present invention, adatabase 36 may be present, as shown schematically in FIG. 8. Thedatabase 36 may be present on a central computer 20 or 34 or on anotherfile server in communication with either one or both of the centralcomputers 20 or 34. The use and usefulness of database 36 in the presentinvention may be further understood in view of some particularlypreferred embodiments.

[0035] In one such embodiment, treatment protocols can be generatedbased upon information gleaned from database 36. The database 36includes a plurality of historic treatment protocol records, the recordsincluding fields populated by parameter data for patientcharacteristics, orthopedic injury, actual treatment protocol followedby the patient, and historic outcome. By “historic treatment protocols”herein is meant actual, accomplished and monitored treatment protocols;and by “historic outcomes” herein is meant the actual, observed recoveryor extent of recovery resulting from such “historic treatmentprotocols.” Additionally, in a most particularly preferred embodiment,the database 36 further includes parameter data selected from the groupof characteristics consisting of demographics, patient physicalcharacteristics, patient psychological characteristics, and theprescribed protocol provided to the patient. In one variation of thisaspect of the present invention, treatment protocols are based uponstatistical analysis of data base records. In another variation, thetreatment protocols are presented to the treatment professional forreview before installing, either all or part, on the handheld computers.That is, the treatment professional is presented with statisticalinformation, such as summaries, means, averages, medians or the like. Ina second variation, the treatment professional is presented with atleast one or more similar individual case histories. Most preferably,the case history is a database record of a patient or patients withsimilar characteristics and similar injuries to the patient about betreated. The data from the database 36 which is presented to a treatmentprofessional for approval, is presented either on screen or in printedform or both; and the data may be presented graphically, textually or acombination of both. The data communicated from the handheld computersmay also be used to update the historic database 36 with the processedpatient compliance information. Use of the data for presentation inorder to allow review by a treatment professional or in updating ahistoric database are not mutually exclusive, and in a most preferredembodiment, the data is used in both ways. It should be understood, thatthe reviewing treatment professional and the treatment professionalinvolved in the earlier approval step are not necessarily the sameindividual. Presented data and updated data may additionally becommunicated and employed for other uses, such as for example,governmental compliance, insurance purposes, and/or financialreimbursement or employment records. Methods of limiting access to thedata in the central computer for confidentiality purposes or financialpurposes are, of course, well known, and might include passwords or, inthe case of intranets and private access networks, may also include callback modems as security enhancements. Internet data communications mayalso be made secure using a variety of means including secure socketlayers (SSL), encryption, passwords, keys or the like.

[0036] Consistent with capabilities of a handheld computer such as, byway of example, the SMART IDEA™ device, the handheld computer may alsoinclude patient signaling capabilities selected from the groupconsisting of audible signaling, visual signaling, and tactilesignaling. Similarly, the handheld computer may include inputcapabilities selected from the group consisting of RS-232 input, sensorsignal input, USB input, modem input, keyboard input, audible input,light input, RF input, IR input and Ethernet input. Moreover, thehandheld computer may include output capabilities selected from thegroup consisting of RS-232 output, USB output, parallel port output,light output, textual, graphical, audible output, Ethernet input,tactile and vibrational output. In addition, the handheld computerdisplay may include any number of languages including English, Spanish,and other foreign languages. Also, the displayed graphics may be visualin nature such that non-literate patients and children may readilyunderstand and use the device.

[0037] In one embodiment, the treatment professional 18 or 30 has theinitial opportunity to query the database 36 with at least someparameters characteristic of the current patient 12 or 24 and thecurrent patient's orthopedic injury. A query computer program 40, ofFIG. 9, is present in the server computer system to query the database36. This allows the database 36 to be searched for similar casehistories in the form of historic records of treatment protocols andoutcomes. Alternatively, the query computer program might be used toreturn statistical information relevant to the patient 12 or 24.

[0038] In an extension of these treatment processes, the treatmentprofessional 18 or 30 may modify the initial query, to increase ordecrease the number of returned records. Additionally, the historicdatabase 36 may allow queries for predicting the likely outcome of atreatment protocol for a patient 12 or 24 with a particular set ofcharacteristics and a particular orthopedic injury. Using this approach,a treatment professional 18 or 30 can rapidly investigate the efficacyof a range of possible treatment protocols which they might envision forthe patient 12 or 24 with a particular orthopedic injury to be treated.Additionally, once at least one treatment protocol is presented, to thetreatment professional 18 or 30, they may either modify the presentedprotocol or the patient characteristics and either re-query the database36 for likely outcomes or proceed to approve the protocol as indicatedin FIG. 10 at 110. It is further provided that the treatmentprofessional may utilize the query program 40 and historical database 36as part of the treatment system of this invention to simulate anevaluation of a treatment protocol under consideration for a particularpatient, then re-modify the treatment protocol based upon the simulationoutputs.

[0039] It is also part of the present invention that the treatmentprofessional may, in modifying the treatment protocol, select fromvarious pre-recorded sound files, one or more patient directed voicecomments, or record one or more individualized, i.e. customized voicecomments, for the patient. As mentioned previously, the sound files maybe played later for the patient as part of the treatment protocol orconditionally played as part of the treatment protocol. If the handheldcomputer 16 or 28 includes the capability to play sound files, then thefiles are played via the handheld computer 16 or 28. Alternatively, thehandheld computer 16 or 28 may signal the patient to play the recordedfile, for example, by displaying a message on an LCD screen for thepatient to do an added motivational or instructional task such as“Listen side #2 cassette recording!” to cause the patient to play ananalog cassette recording of reproduced sound selected by or customrecorded by the treatment professional, or alternatively, the patientmight be instructed by a displayed message to listen to a sound which istransmitted to the patient over the Internet as a sound file by amessage such as “Listen to file PATIENT.WAV!” In another variation ofthis aspect of the process, the sound files may be provided to thepatient as a set of sound files on a device in communication with thehandheld computer 16 or 28 such that the device is instructed to play aparticular sound file. By way of example, this variation may involve acompact disc recording of one or more sound track files of patientdirected comments and a communication link between the hand-heldcomputer 16 or 28 and a compact disc player device, with the ability tobe controlled by a handheld computer. Such control might be by a directwire communication connection or by an infrared signal originated by thehandheld computer 16 or 28. The compact disc may be recorded withgeneric patient directed voice comments or customized comments, such asthe treatment professional's voice recording of custom instructionsand/or encouragement for the particular patient. In the case of custominstructions, the treatment protocol modification step further includesthe treatment professional recording the customized patientinstructions, and the generation step, described earlier, furtherincludes the substep of recording the track onto a recordable orrewritable compact disc.

[0040] In another embodiment, failure of the patient 12 or 24 to complywith the treatment protocol indicated the necessity of a centrallygenerated intervention or modification, either with or withoutpresentation to and review by the treatment professional 18 or 30.Failure to comply may include under or over exercise which deviates fromthe treatment protocol. Alternatively, the monitoring and alertingfeatures (which identify accidents, harmful events, or other incidentsof significance in patient exercise) can be used to alert the treatmentprofessional.

[0041] In yet another embodiment, a script corresponding to thetreatment protocol may further include conditional logic. Mostpreferably, the conditional logic incorporated within the script servesto further treatment goals; that is, the goal-based conditional logicfacilitates a patient's overall treatment program by incorporating theability for intervention within the script loaded onto the handheldcomputer. Goal-directed conditional logic, incorporated within thescript of the handheld computer might be best understood as a third formof intervention, distinct from both intervention by the treatmentprofessional (which might be driven by non-real time reports or by realtime information (such as video) and time-based intervention decisionswhich are made at a central computer based upon pre-determined timeperiods. In such an embodiment, the goal-based conditional logic may beused to incorporate the criterion for recognition by the remotelylocated handheld computer 16 or 26 of a failure of compliance by thepatient 12 or 24 and the ability to alter the treatment protocol. Forexample, goal-based conditional logic could be used to monitor apatient's attempts to meet a particular effort or angle objective to bereplicated a set number of times. Detecting that the effort or angle isnot being achieved, the goal-based conditional logic might set a new,lower and easier to achieve level of effort or angle and accordinglyincrease the desired replicate count to at least partially compensatefor the easier exercise. Alternatively, the conditional logic may beused to provide criteria for recognition by the remotely locatedhandheld computer 16 or 28 of meeting and satisfying, ahead of schedule,the treatment goal set by the treatment professional as represented bythe approved treatment protocol. Those skilled in the art will likelyrecognize the particular advantages of incorporating goal-basedconditional logic within a protocol script loaded on a handheld computerand PORD combination. One such advantage is recognizing acceleratedprogress toward a treatment goal and responding appropriately bymodifying the protocol. In many such cases, the treatment protocol goalsmay be raised to more challenging levels to better capitalize upon thepatient's outstanding efforts. This approach holds the potential toprovide a psychological boost to the patient and further allow themotivated patient to progress very rapidly through orthopedic treatment.The alteration of the protocol need not be immediately communicated backto the central computer 20 or 34 but might be saved for latercommunication. Alternatively, the goal-based conditional logic analysiscan be carried out at the central computer, with one result being theproduction of a modification or intervention in the protocol, followedby transmission of the updated protocol from the central computer to thehandheld computer.

[0042] As shown in FIG. 9, the handling (i.e. the communication and theprocessing) of information within the system of the present inventioncan be very complete and yet very efficient in terms of resourceutilization. A treatment professional 18 or 30, uses a PC 22 or 32 toaccess the query program 40 to find protocols from the historic database36 on a central fileserver. The treatment professional can either create102 a fresh new protocol, select an appropriate historic protocol ormodify parameters of an existing treatment protocol, made up of a groupof exercise related parameters. The creation 102 of a treatment protocolis most easily accomplished by using the query program 40 forconsultation of database 36.

[0043] For example, the treatment professional 18 or 30 sits down at PC22 or 32 and selects a protocol from a list of historical protocolsobtained through query program 40 from historic database 36.Alternatively, a list of protocols may be resident locally at thetreatment professional's PC for the same reason. The treatmentprofessional 18 or 30 then optionally modifies parameters of theprotocol based upon particular injury details associated with thepatient. The resulting modified protocol 107 for the patient is thendownloaded 108 via hardwire or wireless communications 112 to theSmartIDEA™ handheld device 16 or 28. The patient 12 or 24, fitted with aPORD 14 or 26, takes the SmartIDEA™ device 16 or 26 home andperiodically does exercises, generally according to instructions fromthe treatment professional 18 or 30 to follow the created protocol 107.As the patient 12 or 24 follows the presented protocol 107, thepatient's exercise activity and progress is monitored. The patient ispresented with reinforcement signals and instructions based uponcomparison of the patient's actual exercise activity to the goals of theprotocol 107. The reinforcement signals to the patient may be in theform of visual signals, audible signals, and/or tactile signals, and mayinclude qualitative or quantitative information about insufficient orexcessive patient exercise as well as more general motivational signals.After partial completion of the prescribed exercise protocol 107, therecorded data can be communicated (i.e. transmitted) 112 to the centralcomputer server 20 or 34 to generate a progress report 114 for viewingby the treatment professional 18 or 30. The reports can be generated andsubsequently presented by a variety of means 116. For example, thepresentation of the reports may be via fax, printer, graphic screendisplay and/or pager display. Transmission 118 of the reports to thetreatment professional 18 or 30 may involve hardwire, wireless, Internetor intranet communications. The treatment professional 18 or 30 mayrespond, after reviewing the reports and exercising judgment about thepatient progress, by intervening through revising the protocol 107 to arevised protocol 109 in order to increase the likelihood or rate ofachievement of acceptable outcome.

[0044] Such an activity pattern can be thought of as a manualintervention. As will be discussed next, however, the system of thisinvention can provide automatic revision of the protocol, and suchautomatic intervention or modification may be performed in real-time, ifdesired.

[0045] In another embodiment, this same process of reviewing reportcompliance and outcome data and revising treatment protocols can beautomated through the use of an analysis interaction algorithm whichfunctions for the treatment professional.

[0046] More specifically, the analysis interaction algorithm performstwo functions (1) analyzing patient performance for reporting orprotocol adjustment, (2) automatically adjusting or updating a patientprotocol. These two activities are explained as follows:

[0047] Patient Compliance to a Prescribed Exercise Schedule.

[0048] This portion of the analysis interaction algorithm performs atally of actual exercises completed, and the actual time of theircompletion, in comparison to the exercises (goal) which were prescribedand the prescribed schedule for those exercises (goal), as prescribed bythe caregiver.

[0049] For example, a patient is prescribed an exercise regimen thatcalls for one exercise per day for 10 days. Upon completion of the10-day period, data from the handheld device is transferred to thecentral computer. This portion of the analysis interaction algorithmcompares goal and actual schedules and concludes or determines that thepatient performed 90 percent of the prescribed exercises. FIG. 11illustrates one realization of a graphical output of this algorithm.

[0050] Exercise Performance Compared to Prescribed Challenge Level ofExercises.

[0051] This portion of the analysis interaction algorithm performs acomparison of patient actual effort expended. This comparison could bebased upon measurements from the orthosis sensors in units, such as limbjoint angle of flexion/extension or muscle strength measured in units oftorque (for example, Ft-lbs). These measured values are compared to theexercise regimen effort goals prescribed by the treatment professional.

[0052] For example, a patient is prescribed an exercise regimen thatcalls for the patient to strive to reach a strength goal of 20 Ft-lbs,as measured by the instrumented orthosis. The patient attempts to reachthis goal but can only meet 15 Ft-lbs. This portion of the analysisinteraction algorithm compares the goal and actual recorded strengthdata and concludes or determines that the patient reached 75% of thegoal strength exercise regimen. FIG. 12 illustrates one realization of agraphical output of this algorithm.

[0053] Exercise Performance Compared to Benchmark Exercise Performanceof the Unaffected, Contralateral Limb.

[0054] This portion of the analysis interaction algorithm performs acomparison of patient actual effort expended with the injured limb, asexplained above, compared to the strength benchmark of the contralateral(uninjured) limb.

[0055] For example, a patient prior to rehabilitation therapy has ameasurement made on the contralateral limb, and the MVC (MaximumVoluntary Contraction) for that normal limb is found to be 60 Ft-lbs, asmeasured by an instrumented orthosis. The patient progresses throughseveral weeks of therapy and near the end, is consistently attainingstrength levels with the injured limb of 50 Ft-lbs. This portion of theanalysis interaction algorithm compares the benchmark and actualrecorded strength data and concludes or determines that the patient hasregained 83.3% of the contralateral limb MVC strength. FIG. 13illustrates one realization of an output of this algorithm.

[0056] Exercise Performance Compared to Statistical Historical Summariesof Past Comparable Patients.

[0057] This portion of the analysis interaction algorithm performs acomparison of patient actual effort and limb recovery levels achieved,at various times in the recovery schedule and in general over the entireduration of the prescribed exercise schedule, with statistical summariesof historical patient data taken from comparable patients with similarinjuries and demographic backgrounds.

[0058] For example, a patient's overall strength and range of motionperformance at weeks 1 through 8 are recorded during the rehabilitationperiod. To arrive at conclusion or determination about how this patientcompares to past patients with the same injuries and using the same (ornearly the same) recovery exercise protocol, this portion of theanalysis interaction algorithm compares actual week 1 through week 8performance of the patient, against data from the historical database,and concludes or determines that the patient has reached 82% overall ofthe expected levels of strength and recovery, compared to thestatistical, historical performance of patients having the same (ornearly the same) injury and demographic background. FIG. 13 illustratesone realization of an output of this algorithm.

[0059] Additionally, the algorithm may output data for reports for otheruse(s), such as insurance company reports to facilitate efficiency ofreimbursements and financial controls. No report is shown but such wouldbe customizable based upon the form desired at an insurance organizationor other non-medical entity.

[0060] Concepts on Protocol/Performance Data Analysis and Feedback:

[0061] To further explain and discuss the concepts regarding theclosed-loop, goal-based, use of compliance data to make futureadjustments to a patient's protocol based upon past performance of thepatient, one might consider the following. This process can be automatedso that as patient performance and compliance data are regularlycollected, an algorithm can monitor the data automatically and adjustand produce updated protocols to be sent to the patient which willdeliver optimally adjusted levels of exercise challenge, consistent witha number of constraints, including goal-based criteria and safety.Referring then to the FIG. 14, three curves are shown:

[0062] 1. Patient Performance/Competence/Compliance is a measure of howwell the patient is complying with the prescribed exercises. A highscore (near 100%) indicates that the patient is doing well and may nolonger be significantly challenged at the current Challenge Level.

[0063] 2. Protocol Challenge Level is a description of the protocoldifficulty level. This level should rise in conjunction with injuryrecovery, but be moderated by safety considerations.

[0064] 3. Accumulated Exercise Units are the measured, actual amount ofwork that the patient has achieved. This quantity can be compared to theexpected amount of work that the patient should achieve, assuming agiven (for example, 80%) level of average compliance.

[0065] Discussion of Operation:

[0066] The patient starts out (point A, FIG. 14) just aftersurgery/injury with an easy exercise protocol. At first, the patientperformance is low, but it steadily rises (B) as swelling and painreduce, and strength is regained. At some point (C) the patient ismastering the current level of challenge (performance levels near 100%)associated with the protocol.

[0067] Recognizing that this goal has been reached, the protocoladjustment algorithm increases the challenge level (D) of the protocol,possibly requiring as well that a minimum required number of exerciseunits (D1) be logged by the patient. In response to this change, patientperformance falls below 100% (E) as the patient now finds greaterchallenge, and a corresponding effort increase required to meet goals.At the same time, the accumulated work units are now rising at a fasterrate (F) since for each minute of exercise, the patient must now exertmore work to meet the protocol goals presented to him, than he had towith the previous, easier challenge level.

[0068] This pattern repeats itself (G, H) as the protocol adjustmentalgorithm continues to sense patient performance, and as a result adapt(modify or adjust) the protocol to ever increasing levels of difficultyso as to keep the patient challenged, strengthening faster, and on theroad to recovery sooner.

[0069] Challenge Level Rates Over Time

[0070] Referring to FIG. 15 for the following discussion, the challengelevels used in progressive protocols will depend on a number of factorsincluding but not limited to:

[0071] Injury type & grade

[0072] Patient demographics (i.e. factors considered include: Athlete,sedentary, etc)

[0073] Past performance of the patient during the current episode (highcompliance track record or low?)

[0074] Safety levels associated with the orthosis

[0075] In FIG. 15, Curve A illustrates a protocol challenge levelprogression (rate) that is aggressive, associated with, for example, aninjury that has no biomechanical usage limitations, (i.e.“indestructible” lesions such as an ACL reconstruction, rodded femur,etc). In these cases the recovery protocol can be as aggressive as istolerable by the patient.

[0076] Curve B in contrast would be associated with a more gradualprogression in challenge level over time, as would be appropriate withvulnerable lesions that cannot safely tolerate a rapid increase inlimb/joint re-use. Examples are a meniscus repair, cartilage implant, orsimilar. A variation in rate (C) might be associated with injuries whichrequire low-level, early protocol therapy, but that will tolerate, atsome point, a switch to a more aggressive protocol.

[0077] For the class of “indestructible” lesions where the exerciseprotocol challenge level (Curve A) can be as aggressive as possible, itmay turn out the most effective protocols are the ones in which patientmotivation is highest. In this case, the protocols which have the mostinteresting, attention-holding and compelling game-theory elements willreveal themselves. These protocols will have the effect of making thepatient want to reach goals despite pain and fatigue barriers (ofcourse, always subject to safety constraints) leading to a more rapidreturn to normal function.

[0078] The intervention, in the form of revised protocol 109, iscommunicated back to the patient's handheld device 14 or 26 (similar toearlier communication (i.e. transmission) 108), which in turn, presentsor communicates to the patient 12 or 24 signals about the revisedprotocol 109.

[0079] In another embodiment, the treatment professional 18 or 30 mayemploy real-time patient interaction 115 via video/audio communications.Such real-time communications 115 include but are not limited to video,audio, telephone, facsimile, wireless (radio, cellular-telephone,television) communications. Alternatively, the treatment professional 18or 30 may employ other interaction means 117 to provide encouragement tothe patient. The patient, thereby, would be provided with guidance andmotivational encouragement to attempt, and hopefully complete, theexercise protocol. Such other interaction means include but are notlimited to TENS, muscle, audible, visual, palpable, animation and videosignals.

[0080] Upon completion 119 of the entire prescribed course of treatment,the treatment professional 18 or 30 may view reports 120 and view afinal report 122. As described earlier, the reports 120 and 122 may bepresented in a variety of ways and communicated or transmitted in avariety of ways 112 126. For example, report presentations may be, butare not limited to fax, printer, graphic screen display or pagerdisplay. Communication or transmission of report data may involvehardwire, wireless, facsimile transmission, Internet or intranetcommunications. The reports may be sent on demand or may be sentautomatically based upon a pre-determined schedule.

[0081] Further detail of the portions of the protocol creation step areshown in FIG. 10. A treatment professional 18 or 30 is presented by thequery program 40 with at least one and possibly a plurality of historicprotocols from the historic protocol database 36. The query program 40uses prior patient parameters, such as demographic information andprevious outcomes, in the database 36 to select protocols most nearlysimilar to the query information input by the treatment professional 18or 30 about the patient to be treated 12 or 24. Alternatively, the queryprogram 40 may access the historical database 36, both of which canreside on the treatment professional's local PC rather than on a centralcomputer. The relevant patient injury characteristics from priorpatients are also present in the database 36 and in the treatingprofessional's query for the current patient.

[0082] A second source of highly relevant patient information isavailable in many cases in the form of performance information,particularly in the form of a measurement such as the maximum voluntarycontraction (MVC), as available from the patient's uninjuredcontralateral limb. By way of further explanation, the patient'sopposite, uninjured limb is presumptively normal and therefore hasperformance which can provide an approximate and appropriate performancegoal or target to be achieved by treatment of the injured limb. Inanother embodiment of the present invention, a treatment professionalmay measure the MVC of a patient's uninjured contralateral limb byemploying a personal orthopedic restraining device in communication witha handheld computer. This embodiment may be summarized as a process forpre-assessing an orthopedic patient with a limb injury by employing apersonal orthopedic restraining device to measure the condition of apresumptively normal contralateral limb. Preferably, the personalorthopedic restraining device is in communication with a handheldcomputer and most preferably both devices are the same units that willbe subsequently utilized in treatment of the patient's orthopedicinjury. One of ordinary skill will recognize that a personal orthopedicrestraining device is capable of measuring other relevant parameters ofthe contralateral limb, for example, angle of joint bending.

[0083] In another embodiment of the present invention, when the MVC ofthe uninjured contralateral limb has been measured, the MVC, oralternatively, an appropriate lower value, such as for example 95% ofthe uninjured contralateral MVC, is set as a treatment goal for theinjured limb. More preferably, at least one of these values, i.e.measured MVC of the contralateral limb or proposed MVC goal, arecompared to demographic MVC values in the historic database. Thiscomparison can be employed to avoid accepting measurement errors and/orto assess the patient's condition relative to demographic norms. In sucha situation, communications are appropriate and it is preferred toemploy communications through the Internet to a query program therebyobtaining information from the historic protocol database.

[0084] As indicated in FIG. 10, the contralateral MVC and/or proposedtreatment MVC data 42 may be used in conjunction with protocols providedfrom the historic database 36 to create an exercise protocol 107. In thetreatment exercise protocol creation process step 102, the treatmentprofessional 12 or 24 interacts with the possible protocols from thehistoric database 36 and may modify the protocols until an exerciseprotocol 107 is acceptable. The treatment professional 12 or 24 thenprovides a final approval by actively selecting an agreement portion 110to allow the exercise protocol 107 to become available for download tothe handheld computer 16 or 28. In addition, the treatment professionalmay update a protocol 107 based upon recent patient performance data 120or direct patient feedback or comments 121 which is obtained at anytimebetween the start of patient treatment and the end of patient treatment.

[0085] In another embodiment, the present invention further facilitatespatient recovery outcomes by producing exercise protocols whichincorporate improved patient motivational aspects. In particular,patient motivation can be improved by reducing tedium and better holdingthe patient's attention. This can be accomplished by making the exerciseprotocols appear as a game to the patient. This is particularly suitablefor patients who are children and can also serve a readily learnedinterface for patients who are illiterate. In this embodiment, thepersonal orthopedic retraining device (PORD) functions as a “joystick”or game control device which is in turn in communication with thehandheld computer (Smart IDEA). The handheld computer functions as apre-processor, modulator, or signal conditioner of game-like informationfrom the PORD. The conditioned or modulated information is communicatedto a central or base computer, preferably, via the Internet or by modemsover a telephone line or by other methods described earlier. In order tobetter understand this embodiment, it may be helpful to envision suchwell-known computerized toys/games as those available from “SEGA” or“PlayStation” in which a player/participant moves a joystick or pressesbuttons to interact with the game and, in particular, the visual displayof the game which is typically represented as a interesting virtualadventure. The handheld computer (for example, a Smart Idea) with an LCDdisplay can be set up to pass outputs into the base computer viakeyboard daisy chain, and the base computer (preferably via an Internetweb site) can be used to generate the sophisticated graphics and presentthe data as an attractive, stimulating and even fun display for thepatient. Programming can be provided that includes regimens that,instead of, by way of example, are separately numbered exercises #1, #2,& #3, are innovative and in particular integrate all of the actions in amore interesting way.

[0086] For example, a indicia on a video screen visible to the patient,such as the “Super Mario” figure or other character representation withwhich a child patient may readily identify, goes out into the world, heencounters a (virtual) dragon or similar virtual hazard that he must(virtually) jump over, which the child patient can only do by (actually)extending his leg to 5 degrees of flexion. Then the child patient has topush against a (virtual) rock to get it out of the path, which requiresan (actual) isometric flexion/contraction at 45 degrees of 15 footpounds. Next, the child patient who is the game participant has to ringa (virtual) gong by kicking a (virtual) ball, which is accomplished bythe child patient doing another (actual) isometric in extension at 23Foot pounds. Then the child patient who is a game participant has tograb a (virtual) paddle and swat away the angry (virtual) bumblebees, ina manner that can resemble a “pong” proprioception game. In other words,the exercises of the protocol do not have to be static, repetious,and/or boring for the patient, since the computer can present theinstructions for the protocol exercises, as a game-like activity, andfurther can randomly alter the order, mix, add entertaining visual andsound information to the patient (i.e. flash, pow, and interestinggraphics). Such presentations would be similar to those are previouslyknown and available with the superior processing capability of the gamebase stations.

[0087] In a further embodiment, multiple patients, particularly forexample two child patients undergoing orthopedic rehabilitation, canplay their protocol performances against each other over the Internet.In such a system, each of the child patients must be identified to thecentral computer to allow the computer to provide “gaming” consistentwith their individually prescribed treatment protocols. The centralcomputer can also handicap the players to keep the game interesting toeach of the multiple players. A “base station” Internet site can havethe capability to randomly create these routines real-time, and evenvary the routines for patients to facilitate recovery from orthopedicinjuries through innovative treatment protocols.

[0088] Although the present invention has been described with referenceto preferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A method of treating a patient using aninstrumented treatment system based on a treatment protocol, the methodcomprising: automatically evaluating and updating the patient'streatment protocol from a remote central computer.
 2. The method ofclaim 1 wherein the instrumented treatment system comprises a treatmentsystem computer and a communication system allowing communicationbetween the treatment system computer and the central computer.
 3. Themethod of claim 2 wherein the treatment system computer is an ambulatorycomputer.
 4. The method of claim 2 wherein the communication system isselected from the group consisting of wireless communication, hard wiredcommunication, phone modem communication, private network communication,public network communication, and Internet communications.
 5. The methodof claim 1 further comprising monitoring a patient's activity relativeto a selected treatment protocol and storing monitored data in thetreatment system computer.
 6. The method of claim 5 further comprisingprocessing the stored monitoring data and communicating the storedmonitoring data to the central computer.
 7. The method of claim 5wherein the monitoring of the patient's activity is performed with aninstrumented orthosis.
 8. The method of claim 7 wherein the instrumentedorthosis fits around two flexibly connected body portions of thepatient.
 9. The method of claim 5 wherein the monitoring of thepatient's activities is performed with a strain gauge.
 10. The method ofclaim 6 wherein the processing of the stored monitoring data isperformed at the central computer to produce processed patient data. 11.The method of claim 10 further comprising updating a historic databasewith the processed patient data.
 12. The method of claim 11 furthercomprising comparing the processed patient data with historic datastored in the historic database using an analysis interaction algorithm.13. The method of claim 12 wherein the evaluating and updating of thepatient's treatment protocol comprises analysis of the processed patientdata and the historic data stored within the historic database.
 14. Themethod of claim 11 wherein the historic database comprises historic dataon previous patients.
 15. A method of treating a patient using aninstrumented treatment system operated based on a treatment protocol,the method comprising: generating information for a specific treatmentprotocol into a form compatible with an ambulatory computer wherein thespecific treatment protocol was selected from a set of treatmentprotocols.
 16. The method of claim 15 further comprising loading thegenerated information into the ambulatory computer.
 17. The method ofclaim 15 further comprising monitoring patient activity relative to anapproved treatment protocol and storing data resulting from themonitoring in the ambulatory computer.
 18. The method of claim 17further comprising communicating data obtained from the monitoring to acentral computer.
 19. The method of claim 18 further comprisingevaluating compliance from the data relative to the approved treatmentprotocol.
 20. The method of claim 18 wherein the communicating to thecentral computer is performed by wireless communication.
 21. The methodof claim 18 wherein the communicating to the central computer isperformed by Internet communications.
 22. The method of claim 16 furthercomprising processing the monitoring data at the central processor toproduce processed data.
 23. The method of claim 22 further comprisingupdating a patient's treatment protocol based upon analysis of theprocessed data.
 24. The method of claim 23 wherein the updating of thepatient's treatment protocol is performed automatically.
 25. The methodof claim 24 wherein updating a patient's treatment protocol comprisesselecting a treatment protocol from a set of treatment protocols.